The Effect of AMP Human Sodium Bicarbonate Lotion on Hydr... | NCT04598386

NCT04598386

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
AMP Human; Park City, UT	UNKNOWN
United States Department of Defense	FED

Description Module

Detailed Description

Design This laboratory study is a randomized, counterbalanced, crossover design involving 20 participants (20 males) from the local community and university. This project will be conducted within the thermal physiology laboratory, complete with a climatic chamber (Cantrol, CES +13/+44) located within the Human Performance Laboratory (HPL) at the University of Connecticut. The investigators expect each interested individual will complete both phases included within the study design within a randomized, counterbalanced order.

Participant grouping orders will be randomly assigned by the project's lead student investigator (Jeb Struder). Each phase will be fairly similar in procedures completed; however, one phase will be completed with a trial that introduces a biomedical intervention (sodium bicarbonate topical lotion; PR group), while the other phase will be completed with a trial that introduces a placebo (PLA group) product similar to the biomedical intervention. Approximately 24 hours should pass between the completion of each session within a phase of the study. Additionally, approximately 3 days should pass between the completion of a phase and the initiation of the next phase (5th session completed).

Environmental Conditions Sessions I, II, and III of both counterbalanced groups (PR and PLA) will all be completed within thermoneutral conditions. Session IV of both counterbalanced groups (PR and PLA) will be conducted within the climatic chamber set to a climate with ambient temperature at approximately 33C (91.4F) and relative humidity at approximately 25%.

Baseline Assessments (PR/PLAI, PR/PLAII, PR/PLA III) Baseline visits should be completed over 3 consecutive days for the establishment of baseline measurements regarding the participant's body weight, dietary behaviors, and hydration status. Each assessment will be performed at the relatively same time of day (early to late morning) and will involve approximately 30 minutes spent within the laboratory space of the Human Performance Laboratory (HPL). All Baseline Assessment sessions will consist of fairly similar data collection procedures and will begin with the participant providing the completed 24-h dietary recall log, thirst perception scale, and filled urine jug to the administrating researcher. Additionally, the participant will be asked to provide a morning urine sample and nude body weight for the assessment of session-specific hydration status and Fluid Retention Index (FRI). Furthermore, once these tasks are completed, an HPL trained researcher will conduct a blood draw for the collection of approximately ½ teaspoon of blood. Each session will deviate slightly in additional tasks required for completion.

Day 1 (PR/PLAI): After the collection of a morning urine sample and nude body weight measurement, the participant's height (for additional anthropometrics) and resting blood pressure (for safety precautions) will be measured. Additionally, after the completion of the blood draw, the final task for this session will be the participant's familiarization to the Cognitive/Perceptual Battery tasks that you will be tested during Session 4 (PR/PLAIV).

Day 2 (PR/PLAII): After the collection of a morning urine sample and nude body weight measurement, the participant will be asked to rest within a comfortable position for approximately 10-15 minutes for the measurement of their resting heart rate.

Day 3 (PR/PLAIII): After the collection of a morning urine sample and nude body weight measurement, the participant will have their body fat percentage measured via handheld Lange Skinfold Calipers.

Intervention Trial (PR/PLAIV) Pre-Testing Procedures Prior to completing all Intervention Trial visits, participants will be asked to drink 500 mL of water before going to bed and an additional 500 mL of water upon waking to ensure proper hydration. If morning sample urine USG is ≤1.020, participants will be cleared to participate. If the participant arrives with a urine USG between 1.020 and 1.025, the subject will be asked to drink an additional 500 mL of water prior to entering the chamber to ensure proper hydration status. If participants arrive at the lab with a urine USG >1.025, the visit will be rescheduled for the following day. In addition to completing a morning urine spot sample, participants will be asked to complete a nude body mass measurement as well as provide their completed thirst perception scale, dietary recall log, and urine jug. Furthermore, using the urine and nude body weight measurements collected, the session-specific FRI will be assessed. Afterwards, the participant will be provided a standardized breakfast. Once the participant has indicated they are finished with their meal, resting blood pressure measurements will be conducted. Once all measurements have been completed, participants will have a venous cannula inserted by an HPL trained research team member. Finally, prior to entering the environmental chamber, participants will be instructed to privately insert the rectal thermometer 10-15 cm beyond the anal sphincter in addition to completing an additional nude body mass measurement and being fitted with a heart rate strap by the administrating research team.

Data Collection - Initial 120-minutes Upon the completion of participant arrival procedures, participants will then be permitted to enter the environmental chamber (~33C [91.4F], ~25% relative humidity) where they will be instructed to sit down and begin a 30-minute period of environmental equilibration. Once this period has been initiated the participant will be asked to complete their baseline measurements in regard to the Cognitive/Perceptual Battery. After the equilibration period has been completed, the participant will have their resting blood pressure measured, provide a baseline blood sample (~11 mL), and then provide both a urine sample and nude body weight measurement. Once all of these tasks have been completed, the participant will be provided approximately 50 g of the topical lotion (i.e. PR Lotion or Placebo) to apply to their upper body. Afterwards, blood samples (~3 mL) will be collected approximately 15- and 30-minutes post-lotion application. Furthermore, the hyperhydration protocol will be initiated at the 30-minute post-lotion application time point. During this time period, the first of 4 fluid boluses will be provided to the participant for consumption with instructions to consume all fluids provided within the allotted 15-minute time period before the provision of their next fluid bolus. Additionally, before the 3rd fluid bolus has been provided for consumption (identified as time point -30 min in Figure 4), another blood sample (~11 mL) will be completed before completing the rest of the hyperhydration protocol.

Hyperhydration Protocol To induce hyperhydration, participants will drink a total fluid volume of approximately 25 mL/kg of fat free mass (FFM) of water. These solutions will be pre-measured and provided within four enclosed water bottles for consumption at a rate of approximately 6.5 mL/kg FFM about every 15 minutes within a duration of approximately 60 minutes.

Topical Solution Procedures Approximately 50 grams of the topical solution will be pre-measured into 2 separate plastic bags and provided to the participant for application. Participants will be instructed to apply the solution primarily to areas of their upper extremities which will include an identified area from the wrist up to the clavicular area of the shoulder in addition to their chest, neck, upper back, midsection, and lower back if enough solution is available. Application will be considered complete when the solution has been transmitted to the skin in a fashion to where no residue from the lotion is visible by researchers from the skin of the participant.

Data Collection - 3-hour Protocol Collection of Blood Samples Aside from the baseline blood sample collected around the -90-minute time point, an initial blood sample will occur at time point 0 min, where approximately 11 mL of blood will be collected via the inserted cannula. Similar blood samples will be collected at time intervals of approximately 60-minutes up to the completion of the data collection protocol, occurring around the 180-minute mark (approximately 3-hours). In total, approximately 72 mL of blood will be collected during the Intervention Trial, which is less than ¼ of the amount of blood collected during a blood donation.

Collection of Urine Samples and Body Weight Measurements For the collection of all urine spot samples, researchers will provide a clean cup and top to seal the capsule. Participants will be asked to provide a sample regardless of urgency to urinate at specific time points during the trial. If the participant is unable to provide a sample at the time point requested, no protocol deviation will be considered as the lack in sample provided will still be used towards the completion of data analysis. Furthermore, if the participant must provide a urine sample without being requested by a research team member, any urine expelled will be added to the amount collected (if any) during the next urine sample collection time point. Additionally, participants will be instructed to complete a measurement of nude body weight completed before the provision of a urine sample. Both the collection of urine samples and measurement of body weight will be completed within the privacy of a bathroom. Aside from the baseline measurement completed around the -90-minute time point, the initial urine sample collection and body weight measurement for the intervention (i.e. PR Lotion or Placebo) will approximately occur at time point 0-minutes and supplementary urine collection and body weight measurement will be completed in 30-minute intervals up to the end of the data collection period, occurring around the 180-minute mark (approximately 3-hours).

Completion of Cognitive/Perceptual Battery Aside from the baseline Cognitive/Perceptual Battery completed around the -115-minute time point, the initial Cognitive/Perceptual Battery will be completed at time point 0-minutes. Completion of supplemental Cognitive/Perceptual Batteries will be continually measured within a 60-minute time interval from time point 0-minutes until the completion of data collection which will coincide with the 180-minute time point (approximately 3-hours).

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PR Lotion Topical Solution	Experimental	Approximately 50 grams of PR Lotion will be applied by the participants to their upper extremities (arms) in addition to their neck, upper back, chest, and midsection if necessary. This lotion will be applied once during the 4th of session of their PR Lotion Phase and will remain on the skin for approximately 4.5 hours.	Other: PR Lotion - AMP Human Performance
Placebo Lotion Topical Solution	Placebo Comparator	Approximately 50 grams of the Placebo Lotion will be applied by the participants to their upper extremities (arms) in addition to their neck, upper back, chest, and midsection if necessary. The only difference in ingredients for this Placebo Lotion will be the exclusion of the sodium bicarbonate ingredient. This lotion will be applied once during the 4th of session of their Placebo Lotion Phase and will remain on the skin for approximately 4.5 hours.	Other: Placebo Lotion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PR Lotion - AMP Human Performance	Other	Sodium Bicarbonate Topical Solution. For use of the PR Lotion solution, consumers are instructed to apply the lotion to areas of the body that have been identified as most likely to use during their activity (i.e. calves and thighs for runners, shoulders and forearms for swimmers, etc.). Moreover, the product can be applied up to 2 hours prior to beginning a workout or event with one use supporting a 4-6 hour workout. AMP Human has also verified the safety of their product as being well tolerated in consumers >2 years of age unless there is a known allergy to an ingredient on the label. Moreover, to the company's knowledge no side effects have been reported per the SAFETY Section at https://amphuman.com/pages/faq.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fluid Retention - Change in Expelled Urine Volume	Assessment of fluid retention via collection of urine volume	Hydration Baseline Day 1
Fluid Retention - Change in Expelled Urine Volume	Assessment of fluid retention via collection of urine volume	Hydration Baseline Day 2
Fluid Retention - Change in Expelled Urine Volume	Assessment of fluid retention via collection of urine volume	Hydration Baseline Day 3
Fluid Retention - Change in Expelled Urine Volume	Assessment of fluid retention via collection of urine volume	Intervention Trial (Day 4) at the -90 minute mark.
Fluid Retention - Change in Expelled Urine Volume	Assessment of fluid retention via collection of urine volume	Intervention Trial (Day 4) at the 0 minute mark.
Fluid Retention - Change in Expelled Urine Volume	Assessment of fluid retention via collection of urine volume	Intervention Trial (Day 4) at the 30 minute mark.
Fluid Retention - Change in Expelled Urine Volume	Assessment of fluid retention via collection of urine volume	Intervention Trial (Day 4) at the 60 minute mark.

Secondary Outcomes

Measure	Description	Time Frame
Fluid Retention - Change in Whole Blood Hematocrit Levels	Assessment of plasma volume shifts which may indicate fluid retention via assessment of changes in hematocrit levels	Hydration Baseline 1
Fluid Retention - Change in Whole Blood Hematocrit Levels

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males within the age range of 18-35 years old.
Individuals who are classified as recreationally active individuals: physical activity performed ≥3 days per week with sessions lasting ≥30 minutes in duration.
Individuals who have been medically cleared for participation in this study by the medical safety monitor.

Exclusion Criteria:

Cannot understand English (written and/or verbally communicated).
Hearing impaired to where verbal communications cannot be understood and/or followed safely.
Individuals who self-report history of complications with psychological disorders or chronic illness (eating disorders, cardiovascular, kidney, liver, metabolic, neuromuscular, pulmonary, and/or sickle cell disease).
Individuals who have chronic health problems that may affect the participant's ability to thermoregulate or sweat normally.
Individuals who have a history of exertional heat illness within the past 3 years.
Individuals who are taking any prescription or non-prescription medication(s) that may specifically impact cardiometabolic, pulmonary, renal, and/or thermoregulatory function (i.e. amphetamines, antihypertensives, anticholinergics, acetaminophen, NSAIDs, aspirin, and water pills).
Individuals who have consumed more than (>3,500 mg) or less than (<2,300 mg) the average amount of sodium consumed per day at time of testing.
Individuals who have consumed more than (>1.8L) or less than (<0.8L) the average amount of fluids consumed per day at time of testing.
Individuals classified as hypertensive while at rest (SBP: ≥140 mmHg and/or DBP: ≥90 mmHg; will be measured during first visit).
Individuals who have not abstained from use of supplements that may affect/enhance hydration status (i.e. creatine, sodium bicarbonate, potassium, magnesium, dandelion, vitamin B6, other natural diuretics) at time of testing.
Individuals who report they are suffering from a fever or current illness at time of testing.
Individuals who are suffering from a current musculoskeletal injury that limits the participant's ability to walk, stand, and/or sit upright in a chair for long periods of time.
Individuals who have an active lesion at the location of topical solution application.
Individuals how are allergic/sensitive to ingredients within the study-specific Topical Lotions: (Menthol [0.5%], sodium bicarbonate (baking soda), water, isopropyl palmitate, lecithin, poloxamer 407, cetyl alcohol, propylene glycol, denatured alcohol, benzyl alcohol, polyglyceryl-4 laurate, sodium hydroxide, sodium lauryl sulfate, sorbic acid, and fragrance).
Individuals who are allergic/sensitive to iodine, water-based ultrasound solution, and/or medical tape.
Individuals who have experienced any recent major life events (i.e. death in family, divorce, wedding) in the previous 6 months.
Individuals who have donated blood within the previous month.
Individuals who have an implanted pacemaker or internal defibrillator.
Individuals who use tobacco products (including smoking cessation products).

ID	Term
D006955	Hypernatremia
D014869	Water Intoxication

ID	Term
D014883	Water-Electrolyte Imbalance
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D011041	Poisoning